The monitoring of adverse events (AE's) is an important aspect in the protection of human subjects enrolled in research protocols. Today, in most places, a substantial portion of our most important resource (our data) is sitting on paper in file cabinets distributed throughout the medical center. The process of collecting, reviewing and circulating updates to this mass of paper has overwhelmed most areas associated with Human Subjects Research. This paper management problem is especially true in regard to managing adverse event reports associated with clinical trials. The ever increasing volumes of AE's (both local and non-local) that must be reviewed by the IRB are swamping our current manual paper-based process. This sets the stage for delays and mistakes when staff can not keep up with the workload. The importance of disseminating relevant AE information to other investigators utilizing that agent, and the need to track actions including consent form modifications can no longer be left to a manual, paper based system. The second phase of this grant proposes to: 1. Continue to integrate the data and work flow processes associated with Clinical Trial research into our existing relational data model and overall process map of the research business. 2. Extend our standard programming environment to support the collection, and distribution of this data to a secure web infrastructure and 3. To share this data model and development environment with other groups performing clinical trials.